Recall Z-1928-2008 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numbers: CB96345-023, CB96345-023, and CB96345-029.
| Date | Jul 24, 2008 (initiated May 9, 2008) |
| Status | Terminated |
| Reason | Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS). |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic issued a Press Release on 05/07/2008. An Urgent Medical Device Recall letter was sent to customers on May 07, 2008. The letter identifies affected devices, explains the situation and requests that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall Certificate acknowledging the receipt of this information. |
| Quantity | 17 US, 29 OUS |
| Distribution | Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924642 | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER Medtronic Bio-Medicus, Inc., Mar 26, 1993 |